By: FDA OCI Public Affairs
The Office of Regulatory Affairs’ (ORA) Office of Criminal Investigations (OCI) has the primary responsibility for criminal investigations conducted by the FDA, as well as all law enforcement intelligence issues pertaining to threats to public health associated with FDA-regulated products and industries.
OCI pursues its mission to protect the health and welfare of the American public by conducting criminal investigations into illegal activities (e.g., distribution of counterfeit or intentionally adulterated products) involving FDA-regulated products such as human and veterinary drugs, vaccines, medical devices, food, cosmetics, dietary supplements, and tobacco products.
OCI agent on the firing range (courtesy photo) / OCI agents conduct training course (courtesy photo) / OCI agent conducts training class (Courtesy Photo)
Since 1993, OCI has investigated thousands of criminal schemes involving a broad range of criminal conduct, including:
• Distribution of counterfeit, unapproved, and misbranded medical products;
• Major organized illicit diversion of prescription drugs;
• Fraudulent schemes involving ineffective AIDS, cancer, and Alzheimer cures;
• Large-scale product substitution conspiracies;
• Application fraud and clinical investigator fraud, and;
• Health fraud involving FDA-regulated drugs and medical devices.
Globalization of Crime
The increasing globalization of crime has created new challenges for OCI and other law enforcement agencies.
Crime involving counterfeit or substandard FDA-regulated products, including pharmaceuticals, is a profitable business. Transnational organized crime groups have been quick to adapt to new opportunities and can be resilient in the face of traditional law enforcement measures.
As part of a multi-tiered FDA-wide strategy, OCI strategically increased the number of international postings around the globe to more effectively combat these and other threats to public health and safety. OCI continues to expand its international network and has special agents permanently embedded with INTERPOL and EUROPOL. OCI also received approval to place a special agent in the U.S. embassy in the United Kingdom and is seeking approval for two additional foreign postings.
Cybercrime and Imports
Given the increased threat to public health and safety posed by illicit regulated products being sold online and distributed via illicit mail shipments, OCI has successfully fielded a world-class cybercrime and import operations program focused on FDA-regulated health and safety products.
OCI is on the forefront of digital crime investigations with special agents and Intelligence Research Specialists specifically trained as cybercrime and digital forensics specialists. These agents pursue sophisticated criminal organizations that threaten public health through use of the internet and are experts at preserving the digital crime scene.
Agents assigned to OCI’s Import Operations Program are on the forefront of FDA-regulated products entering the United States. These agents work alongside U.S. Customs and Border Protection officers and FDA civil investigators at border or land crossing, international mail facilities, express courier hubs, and seaports to stop illicit products from entering the United States.
The type of investigations pursued by these groups frequently focus on unauthorized foreign distributors seeking to penetrate the FDA-regulated pharmaceutical supply chain, counterfeit opioid products marketed on the surface and dark nets, and the large-scale smuggling of regulated health and safety products utilizing international free trade zones and postal carries.
OCI special agents are dedicated to protecting the health and welfare of the public by investigating criminal allegations falling within FDA’s jurisdiction. Incoming agents receive four weeks of initial training at the Federal Law Enforcement Training Center in Charleston, SC. OCI special agents receive initial and continuing advanced instruction in FDA food and drug law, interviewing techniques, financial crimes, computer forensics, asset forfeiture, legal education, and internet investigations.
OCI maintains a list of its Most Wanted Fugitives to help bring these international fugitives to justice and protect the health of all citizens.
For more information, visit the FDA Office of Criminal Investigations Website at https://www.fda.gov/ICECI/CriminalInvestigations/default.htm.